Univentricular Heart Clinical Trial
Official title:
Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
The primary objective of this investigation is to evaluate the feasibility and safety of implantable loop recorder implantation (using the LUX-DX™) in newborns undergoing stage 1 palliation. The secondary objective of the investigation is to evaluate the feasibility of continuous measurement of heart rate and arrhythmia using an implantable loop recorder (LUX-Dx™) during the interstage period. An implantable loop recorder will be placed at the time of chest closure following stage 1 palliation (either at the time of index surgery or delayed). The device will be placed in a subclavicular pouch through the existing sternotomy incision. Participants will be in the study for 6 months to 3 years.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | September 10, 2027 |
Est. primary completion date | September 10, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 30 Days |
Eligibility | Inclusion Criteria: - Patients with single ventricle physiology undergoing stage 1 palliation in the 1st month of life Exclusion Criteria: - Prematurity (<36 weeks gestational age) - Birth weight <2.5 kg - Hybrid stage 1 palliation (patent ductus arteriosus stenting, bilateral pulmonary artery bands) - Presence and/or need for devices sensitive to magnetic fields such as hearing aids, pacemaker, and other implanted devices. - Clinical team does not think that the patient is a good candidate |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with successful ILR implantation at the time of surgery | Feasibility of ILR implantation | At the time of stage 1 surgery, typically the first week of life | |
Primary | Number of patients with ILR related complication (any of: infection, erosion, device migration, foreign body rejection phenomena, formation of hematomas or seromas, local tissue reaction and/or tissue damage | Safety of ILR implantation | Between the stage 1 and stage 2 surgery, typically until 4-6 months of age | |
Secondary | Number of patient who completed >70% planned ILR transmissions | Between the stage 1 and stage 2 surgery, typically until 4-6 months of age | ||
Secondary | Number of patients with arrhythmias | Any arrhythmia, including supraventricular tachycardia, junctional ectopic tachycardia, ventricular tachycardia, atrioventricular block, pause >2.5 seconds | Between the stage 1 and stage 2 surgery, typically until 4-6 months of age | |
Secondary | Number of patients with interstage complication | Any complication, including unplanned emergency department visit, unscheduled hospital admission, unscheduled intensive care unit admission, arrhythmias, major interstage intervention, minor interstage intervention, cardiac arrest, death | Between the stage 1 and stage 2 surgery, typically until 4-6 months of age | |
Secondary | Complications at the time of ILR removal | Defined as easily removed, removed with difficulty, removed with complication | At stage 2 or 3 palliation, typically between 4 months and 4 years of age |
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